Prospective, Open-Label, Multi-Center ProceDural Data CollectIon Case Registry on NeVa VS for CerebraL VAsospasm ManagemenT in Post SAH PatiEnts (The DILATE Registry)
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY
A multi-center, observational registry study intended to assess the HDE-approved NeVa VS cerebral artery dilation device in patients with symptomatic cerebral vasospasm caused by aneurysmal subarachnoid hemorrhage (aSAH)
Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:
• Age ≥22
• Symptomatic cerebral vasospasm secondary to aneurysmal subarachnoid hemorrhage (aSAH) in the internal carotid artery (ICA), middle cerebral artery (MCA), anterior cerebral artery (ACA), posterior cerebral artery (PCA), or basilar artery (BA)
• Vessel dilation procedure was performed with the NeVa VS
• Subject or legal representative is able and willing to give informed consent within 3 days (72 hours) post-index procedure
Locations
United States
California
Providence St. Joseph Medical Center
RECRUITING
Burbank
John Muir Health
RECRUITING
Walnut Creek
Connecticut
Yale
RECRUITING
New Haven
Florida
Baptist Health South Florida
RECRUITING
Miami
Georgia
Wellstar Health System
RECRUITING
Marietta
Iowa
Univ Iowa
RECRUITING
Iowa City
Illinois
Endeavor Health
RECRUITING
Evanston
Kentucky
Univ Kentucky
RECRUITING
Lexington
Maine
MaineHealth
RECRUITING
Portland
Minnesota
Mayo Clinic- Rochester
RECRUITING
Rochester
Pennsylvania
Allegheny Health Network
RECRUITING
Pittsburgh
Geisinger
RECRUITING
Wilkes-barre
Texas
Valley Baptist Medical Center- Harlingen
RECRUITING
Harlingen
University of Texas Health Science Center at Houston
RECRUITING
Houston
Utah
Uni. of Utah
RECRUITING
Salt Lake City
West Virginia
West Virginia University
RECRUITING
Morgantown
Contact Information
Primary
Sharon Shachar, Graduate
sshachar@vesalio.com
2486976616
Time Frame
Start Date: 2025-04-14
Estimated Completion Date: 2027-03-15
Participants
Target number of participants: 200
Treatments
Treatment Group
Related Therapeutic Areas
Sponsors
Leads: Vesalio